EVOLVE: A Prospective Randomized Multicenter Single-blind Non-inferiority Trial to Assess the Safety and Performance of the Evolution Everolimus-Eluting Monorail Coronary Stent System (Evolution Stent System) for the Treatment of a De Novo Atherosclerotic Lesion

Boston Scientific Corporation29 sites in 9 countries291 target enrollmentJuly 2010

ConditionsCoronary Artery Disease

Overview

Phase: Not Applicable
Intervention: Not specified
Conditions: Coronary Artery Disease
Sponsor: Boston Scientific Corporation
Enrollment: 291
Locations: 29
Primary Endpoint: Composite safety endpoint of Target Lesion Failure (TLF) at 30 days post-procedure
Status: Completed
Last Updated: 9 years ago

Overview Investigators Eligibility Criteria Outcomes Sites Similar Trials

Overview

Brief Summary

The purpose of the EVOLVE Trial is to assess the safety and performance of the everolimus-eluting Evolution stent for the treatment of a de novo atherosclerotic lesion of up to 28 mm in length in a native coronary artery 2.25 mm to 3.5 mm in diameter. The safety and performance of two different drug release rate formulations of the Evolution Stent will be compared to the commercially available PROMUS (TM) Element (TM) drug-eluting stent.

Registry

clinicaltrials.gov

Start Date

July 2010

End Date

April 2016

Last Updated

9 years ago

Study Type

Interventional

Study Design

Parallel

Sex

All

Investigators

Sponsor

Boston Scientific Corporation

Responsible Party

Sponsor

Eligibility Criteria

Inclusion Criteria

•Patient must be at least 18 years of age
•Patient (or legal guardian) understands the trial requirements and the treatment procedures and provides written informed consent before any trial-specific tests or procedures are performed
•Patient is eligible for percutaneous coronary intervention (PCI)
•Patient has symptomatic coronary artery disease or documented silent ischemia
•Patient is an acceptable candidate for coronary artery bypass grafting (CABG)
•Patient has a left ventricular ejection fraction (LVEF) ≥30% as measured within 60 days prior to enrollment
•Patient is willing to comply with all protocol-required follow-up evaluations

Exclusion Criteria

•Patient has clinical symptoms and/or electrocardiogram (ECG) changes consistent with acute MI
•Patient with unstable angina or recent MI (within 72 hours) must have CK/CK-MB or troponin documented prior to the procedure and are excluded if any of the following criteria are met at the time of the index procedure:
•If CK MB \>2× upper limit of normal (ULN), the patient is excluded regardless of the CK Total.
•If CK Total \>2× ULN, either CK-MB or troponin must be drawn and the patient is excluded if either CK-MB or troponin is abnormal.
•If neither CK Total or CK MB is drawn but troponin is, the patient is excluded if:
•Troponin \>1× ULN and the patient has at least one of the following:
•Patient has ischemic symptoms and ECG changes indicative of ongoing ischemia (e.g., \>1 mm ST segment elevation or depression in consecutive leads or new left bundle branch block \[LBBB\])
•Development of pathological Q waves in the ECG; or;
•Imaging evidence of new loss of viable myocardium or new regional wall motion abnormality Note: Patients with stable angina must have CK/CK-MB or troponin drawn prior to the index procedure. However, the results for these patients do not need to be available prior to the index procedure and there are no exclusion criteria based on these studies.
•Patient has received an organ transplant or is on a waiting list for an organ transplant

Outcomes

Primary Outcomes

Composite safety endpoint of Target Lesion Failure (TLF) at 30 days post-procedure

Time Frame: 30 days

Composite safety endpoint of Target Lesion Failure (TLF) at 30 days post-procedure: * Cardiac Death related to target vessel * Target Vessel Myocardial Infarction (TV-MI) * Target Lesion Revascularization (TLR)

In-stent late loss at 6 month post-procedure

Time Frame: 6 months post-procedure

In-stent late loss at 6 months post-procedure measured by Quantitative Coronary Angiography (QCA)

Secondary Outcomes

Target lesion revascularization (TLR) rate at 30 days, 6 months, 9 months, 1 year, 2 years, 3 years, 4 years and 5 years(30 days, 6 months, 9 months, 1 year, 2 years, 3 years, 4 years and 5 years)
Cardiac death rate at 30 days, 6 months, 9 months, 1 year, 2 years, 3 years, 4 years and 5 years(30 days, 6 months, 9 months, 1 year, 2 years, 3 years, 4 years and 5 years)
Target vessel revascularization (TVR) rate at 30 days, 6 months, 9 months, 1 year, 2 years, 3 years, 4 years and 5 years(30 days, 6 months, 9 months, 1 year, 2 years, 3 years, 4 years and 5 years)
Non-cardiac death rate at 30 days, 6 months, 9 months, 1 year, 2 years, 3 years, 4 years and 5 years(30 days, 6 months, 9 months, 1 year, 2 years, 3 years, 4 years and 5 years)
Target lesion failure (TLF) rate at 30 days, 6 months, 9 months, 1 year, 2 years, 3 years, 4 years and 5 years(30 days, 6 months, 9 months, 1 year, 2 years, 3 years, 4 years and 5 years)
Target vessel failure (TVF) rate at 30 days, 6 months, 9 months, 1 year, 2 years, 3 years, 4 years and 5 years(30 days, 6 months, 9 months, 1 year, 2 years, 3 years, 4 years and 5 years)
MI rate (TV and overall)at 30 days, 6 months, 9 months, 1 year, 2 years, 3 years, 4 years and 5 years(30 days, 6 months, 9 months, 1 year, 2 years, 3 years, 4 years and 5 years)
Stent thrombosis rate (by Academic Research Consortium [ARC] definition)at 30 days, 6 months, 9 months, 1 year, 2 years, 3 years, 4 years and 5 years(30 days, 6 months, 9 months, 1 year, 2 years, 3 years, 4 years and 5 years)